Regulatory Affairs Specialist – Regulatory Business Solutions
BD
full-time
Posted on:
Location Type: Hybrid
Location: San Agustin del Guadalix • 🇪🇸 Spain
Visit company websiteSalary
💰 €35,000 - €42,000 per year
Job Level
Mid-LevelSenior
About the role
- Responsible for supporting and executing regulatory activities across multiple projects and UCC and Surgery product lines
- Reviewing and approving advertising and promotional materials to ensure compliance with regulatory legislations
- Maintaining and updating the Technical Documentation Repository
- Addressing product-specific regulatory queries from local teams
- Leading non-product-specific regulatory projects
- Overseeing label review and approval processes
- Collaborating with quality teams to provide regulatory input on First Article Inspection
- Supporting regional initiatives for CE marking and other regulatory asks
- Serving as a subject matter expert on EU regulations
Requirements
- Bachelor’s degree in Life Sciences, Biomedical Engineering, or a related field (Master’s degree preferred)
- 3-5 years of experience in regulatory affairs, preferably within the medical device, pharmaceutical, or life sciences industries
- Experience with EMEA regulatory standards and CE mark requirements is strongly preferred
- Proficiency in managing regulatory documentation, labeling requirements, and documentation repositories
- High level of accuracy in reviewing and approving labeling, advertising, and promotional materials
- Strong collaborative skills and a proactive approach to support functions and business unit-specific projects
- Strong proficiency in English written and spoken.
Benefits
- Health insurance
- Retirement plans
- Paid time off
- Professional development opportunities
- Competitive package of compensation and benefits
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory affairsregulatory documentation managementlabeling requirementsadvertising compliancepromotional materials reviewTechnical Documentation Repository maintenanceFirst Article InspectionCE markingEMEA regulatory standardsaccuracy in documentation
Soft skills
collaborative skillsproactive approachcommunication skillsleadershipproblem-solving
Certifications
Bachelor’s degree in Life SciencesBachelor’s degree in Biomedical EngineeringMaster’s degree in related field